{"id":759324,"date":"2026-09-04T04:28:16","date_gmt":"2026-09-04T04:28:16","guid":{"rendered":"https:\/\/www.newsbeep.com\/uk\/759324\/"},"modified":"2026-09-04T04:28:16","modified_gmt":"2026-09-04T04:28:16","slug":"nzs-new-medicines-fast-track-promises-quicker-approvals-but-what-about-access","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/uk\/759324\/","title":{"rendered":"NZ\u2019s new medicines fast-track promises quicker approvals. But what about access?"},"content":{"rendered":"

A surge in severe respiratory illness has been placing New Zealand\u2019s hospitals under intense pressure over recent weeks. While influenza has been the main driver, rhinovirus<\/a> and respiratory syncytial virus (RSV)<\/a> have also contributed to the unusually high patient load<\/a>.<\/p>\n

Babies and young children carry a disproportionate share of RSV disease. In a typical year, around 1,800 to 2,000 children under five<\/a> are hospitalised with RSV, about half of them infants. M\u0101ori and Pacific infants, along with children living in deprived or crowded households, are disproportionately affected.<\/p>\n

With this year\u2019s increased RSV activity has come renewed calls<\/a> for wider access to medicines which target the virus and are already used elsewhere. Just this week, an online Horizon Research survey<\/a> found 70% of respondents supported publicly funded RSV immunisation for eligible infants and during pregnancy.<\/p>\n

This also comes at an important point for RSV prevention in New Zealand. On July 23, Medsafe approved<\/a> the ready-made antibody injection nirsevimab, sold under the brand name Beyfortus. Pharmac has meanwhile placed it on its Options for Investment list<\/a>.<\/p>\n

New Zealand thus has an approved RSV preventive medicine without a publicly funded programme offering it to infants generally. That gap provides a practical test of the government\u2019s efforts to improve access to medicines.<\/p>\n

Faster regulatory approval can help, but approval alone does not set a price, secure supply, fund a medicine or establish a programme to deliver it.<\/p>\n

A faster pathway, with exceptions<\/p>\n

Several new RSV prevention options are now being used overseas. The vaccine Abrysvo<\/a> is given during pregnancy, stimulating antibodies that pass through the placenta and help protect the baby during its first months of life.<\/p>\n

Nirsevimab<\/a> and clesrovimab<\/a>, sold as Enflonsia, are long-acting antibodies given directly to infants. For most babies, maternal vaccination and an infant antibody are alternative ways of providing protection.<\/p>\n

Australia has approved all three medicines. Abrysvo has been available free<\/a> to eligible pregnant women under its National Immunisation Program since February 2025, while states and territories also fund<\/a> nirsevimab for some infants and young children.<\/p>\n

New Zealand\u2019s publicly funded response remains much narrower.<\/p>\n

Pharmac has funded<\/a> the older antibody palivizumab since January 2025 for infants and young children at very high risk of severe RSV disease.<\/p>\n

Nirsevimab has since received a high-priority recommendation from Pharmac\u2019s advisers and progressed to its Options for Investment list. Infant clesrovimab and maternal Abrysvo<\/a> have also received provisional high-priority recommendations.<\/p>\n

But these steps do not guarantee funding<\/a>, which ultimately remains Pharmac\u2019s decision. Meanwhile, Medsafe\u2019s new verification pathway <\/a>came into force on July 3.<\/p>\n

Medicines with full approval from at least two recognised overseas regulators can potentially receive a decision within 30 working days once an eligible application has been accepted.<\/p>\n

This reliance model makes sense for a small country. Medsafe can draw on rigorous assessments already completed by trusted overseas regulators rather than repeating all their work.<\/p>\n

Nirsevimab\u2019s July approval, however, should not be attributed to the new pathway. Its Gazette notice records consent under section 20 of the Medicines Act rather than consent by verification.<\/p>\n

The new pathway also has important limits. Medicines requiring an independent New Zealand assessment are deliberately excluded, including innovative medicines indicated exclusively for children or pregnant people.<\/p>\n

This does not prevent such medicines from being approved. It means they must use another assessment pathway. On the published rules, applications limited to the infant uses of nirsevimab or clesrovimab would appear to fall within this exclusion.<\/p>\n

Abrysvo is more complicated because overseas approvals also cover older adults, meaning eligibility would depend on the uses sought in New Zealand and the overseas approvals supporting them.<\/p>\n

Moving from approval to access<\/p>\n

Getting a medicine to patients in New Zealand involves several distinct decisions.<\/p>\n

Medsafe assesses its quality, safety and efficacy<\/a> and decides whether it may be marketed. Pharmac decides whether and how it will be publicly funde<\/a>d, while health services must then procure, distribute and administer it. It may also need to negotiate price and supply arrangements.<\/p>\n

Health New Zealand and healthcare providers must then establish and deliver the programme, including its eligibility rules, workforce, logistics, communications and administration.<\/p>\n

Some of these processes can overlap. Pharmac can undertake parallel assessment<\/a> while Medsafe considers regulatory approval.<\/p>\n

But faster Medsafe assessment cannot compel a supplier to submit a New Zealand application, agree on an acceptable price, guarantee sufficient supply or establish a delivery programme.<\/p>\n

So, will the new verification pathway actually get medicines to New Zealanders sooner? It is still too early to tell.<\/p>\n

When the pathway opened, the Ministry of Health said<\/a> several pharmaceutical companies had signalled interest and Medsafe had begun discussing potential applications with them.<\/p>\n

But as of August 28, Medsafe had not published pathway-specific figures showing how many applications had been submitted, validated, accepted, redirected to another pathway or decided.<\/p>\n

Greater transparency would make the reform easier to evaluate. Publishing application numbers and decision times alongside Pharmac\u2019s funding timelines would show more clearly how long medicines take to reach patients.<\/p>\n

Nirsevimab makes the distinction between approval and access particularly clear. It has regulatory approval and has progressed through Pharmac\u2019s assessment process, but broad publicly funded access has yet to follow.<\/p>\n

New Zealand\u2019s verification pathway should shorten regulatory assessment for medicines that qualify.<\/p>\n

The true test will be how much sooner the whole system delivers protection to patients, particularly the M\u0101ori and Pacific infants who carry a disproportionate share of the RSV burden.<\/p>\n","protected":false},"excerpt":{"rendered":"A surge in severe respiratory illness has been placing New Zealand\u2019s hospitals under intense pressure over recent weeks.…\n","protected":false},"author":2,"featured_media":759325,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[102,6591,56,54,55],"class_list":["post-759324","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-medication","tag-uk","tag-united-kingdom","tag-unitedkingdom"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/759324","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=759324"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/759324\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/759325"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=759324"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=759324"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=759324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}